About HBV and HDV

Hepatitis B (HBV) and hepatitis D (HDV) are major global health threats, responsible for a significant portion of liver cirrhosis and liver cancer cases worldwide. HBV affects over 250 million people chronically, and HDV—a rare disease that only occurs in HBV carriers—impacts an estimated 12 million individuals. Together, they contribute to
approximately 800,000 deaths each year. HDV infection in particular leads to much more rapid progression toward liver failure and cancer compared to HBV alone.

Despite the availability of a prophylactic vaccine for HBV, which also protects against HDV infection, the number of chronic cases continues to rise.

SVF Vaccines lead vaccine candidate SVF-001 is being developed as a curative immunotherapy for hepatitis D, and building on robust preclinical data, is now preparing for a Phase 1 study.​

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The care of HBV and HDV today

Today, there are no curative treatments for HBV or HDV. For HBV, existing therapies must be taken for life. While they can suppress the virus in the bloodstream, they do not eliminate it from infected liver cells, leaving patients vulnerable to long-term complications. HDV treatment options are even more limited, with only a few therapies available—none of which offer a cure.

This ongoing reliance on lifelong management, in the absence of curative solutions, underscores a high and urgent unmet medical need. The current approach is not enough. To reverse the global trajectory of these diseases and achieve the WHO’s 2030 hepatitis elimination goals, we must go beyond prevention and invest in the development of curative therapies.

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The competition

Existing therapies for chronic HDV are highly expensive, cumbersome, and do not result in sustained responses. Bulevertide is a competitive receptor inhibitor that is injected daily over a three year period with <10% of sustained responses. The cost is 70.000 EUR/year.

Monoclonal antibodies are being developed that may be more effective but highly expensive. SVF Vaccines vaccine immunotherapy is the only therapy that trains the host immune system to fight and clear the infection.

Additionally, SVF-001 is set to provide significant upsides compared to current and future HDV therapies:

• fewer injections;
• better effect with three mechanisms of action and;
• lower manufacturing costs

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The Market 

The market for hepatitis D therapeutics is estimated to reach 1 billion USD in 2032. The area presents an attractive exit landscape, e.g. Gilead acquisition of Myr for $1.7B in December 2020.